510(k) · Cleared
Recalled · Class III · 2016Reticcount Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Becton Dickinson Vacutainer Systems Preanalytic · GKL Counter, Cell, Automated (Particle Counter)
Cleared on Mar 21, 1988 after a 34-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled once.
- Decided
- Mar 21, 1988
- Review
- 34 days
- Class
- Class II
- Product code
- GKL
- Recalls
- 1
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK880636 Reticcount SoftwareBd Becton Dickinson Vacutainer Systems Preanalytic · 1988
- Descendant · cites it directly · 0 of its ownK990327 Reticone System for Epics XL Flow Cytometry SystemsCoulter Corp. · 1999
- Descendant · cites it directly · 0 of its ownK953302 Facs Loader SystemBecton Dickinson Immunocytometry Systems · 1995
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K880636 | Reticcount Software | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988 | — |
| +1 | K990327 | Reticone System for Epics XL Flow Cytometry Systems | Coulter Corp. | 1999 | — |
| +1 | K953302 | Facs Loader System | Becton Dickinson Immunocytometry Systems | 1995 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 18, 2016 | Class III | Z-1390-2016 | Under Investigation by firm | The carton label for one lot of BD Retic-Count Reticulocyte Reagent System had the incorrect storage conditions. The labels on the reagent as well as the Instructions for Use are correct. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K990327 (Coulter Corp., 1999) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GKL devicesGKL Counter, Cell, Automated (Particle Counter): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GKL
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GKL
Too few GKL 510(k)s in any year since 2007 to give a median.
Recalls per year · GKL
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKL
1in 2025
MAUDE reports naming product code GKL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 25 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 1 | 31 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 1 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 11 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K880636 · printed Nov 6, 2026
Cite this page
510(k) Report. “K880636: Reticcount Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K880636
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026